Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.

A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis

Ambulatory men at least 30 years old at screening, who are diagnosed with primary, idiopathic or hypogonadal osteoporosis according to the following criteria: Femoral neck (FN) BMD T-score < -2.0 and LS BMD T-score < -1.0 OR LS BMD T-score < -2.0 and FN BMD T-score < -1.0 and BMD T-score > 4.0 at any site

Subjects who, in the opinion of the investigator, are willing and able to comply with the protocol requirements

Subjects who have signed an informed consent

Exclusion criteria:

Significant medical conditions or laboratory abnormalities, which in the opinion of the investigator may preclude the patient's ability to complete the study

Subjects who are receiving testosterone supplementation for < 2 years (if applicable) (Patients who are identified with clinical signs of hypogonadism at screening and are started on testosterone supplementation will be excluded from participation.)

Contraindications to calcium or vitamin D therapy

Administration of any investigational drug within 30 days preceding the first dose of the study drug

Previous treatment with an oral bisphosphonate within the last six months, OR more than one month of cumulative treatment within the last year, OR more than three months of cumulative treatment within the last two years AND/OR treatment with intravenous bisphosphonate within one year.

Treatment with PTH or similar anabolic agent for osteoporosis within the last two years

Treatment with other drugs affecting bone metabolism within the last six months prior to Screening including:

Chronic systemic glucocorticoid treatment except for topical treatment at a frequency of up to twice per week

Any restrictions, defined by site requirements for hrMRI procedure (for subset of hrMRI subjects)

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00397839